Spotlight on e-cigs – National Consumers League

The Food and Drug Administration announced in April proposed new regulations that would cover for the first time e-cigarettes as well as other tobacco products, including pipe tobacco, cigars and waterpipe (hookah) tobacco. Electronic (or e-cigarettes) have become a huge billion dollar industry which had escaped federal oversight until now. As tobacco remains the leading cause of death and disease in this country, this expanded FDA oversight is an important moment for consumer protection.

As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by President Obama in 2009, the rule sets forth additional tobacco products that would be “deemed” to be subject to FDA regulation. “This proposed rule is the latest step in our efforts to make the next generation tobacco-free,” said HHS Secretary Kathleen Sebelius.

Under the proposed rule, makers of these tobacco products would, among other requirements:

  • Register with the FDA and report product and ingredient listings;
  • Only market new tobacco products after FDA review;
  • Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole;
  • Not distribute free samples;
  • Have minimum age and identification restrictions to prevent sales to underage youth;
  • Include health warnings on the products; and
  • Prohibit vending machine sales, unless in a facility that never admits youth.

E- cigarettes resemble traditional cigarettes but they use a heat source, usually powered by a battery, to turn a liquid that usually contains nicotine and flavorings, into an aerosol that is inhaled by the user. Over the last few year e-cigarette usage has exploded, with a doubling of e-cigarette use from 2011 to 2012 among middle and high school students and adults (18-34), according to the Centers for Disease Control (CDC) figures.

Of concern to public health experts is that e-cigarette makers appear to be targeting youth. E-cigarette makers spent $39 million on ads from June through November 2013, much of it on programming targeting youth, the anti-tobacco organization Legacy found. The fear is a whole new generation of people will become addicted to nicotine.

Of note to anti-smoking advocates is that the proposed rule does not contain any proposal to ban flavors in e-cigarettes or cigars. They worry that e-cigarettes sold in flavors such as bubble gum and gummi bear will entice teenagers and children. Public health experts say 90 percent of smokers start by the age of 20.

There are also was no suggestion in the proposed rule to restrict the marketing of e-cigarettes, as is done for regular cigarettes, which are banned from television advertising. According to Legacy, while cigarette advertising is prohibited on television, it is currently fair game to use television to promote electronic cigarettes. Using broadcast and online advertising has allowed the e-cigarette industry to promote its products in a way that has broad reach.

While the proposed regulation takes some very important steps to protect public health by regulating these new tobacco products, especially e-cigarettes, it is essential that FDA continue to look at what further regulation is needed to ensure these products are not marketed to youth.

The proposed rule will be available for public comment for 75 days. The FDA is particularly interested in comments on how cigars should be covered by the rule, and how e-cigarettes should be regulated.

Consumer health advocates continue work on health coverage at the Families USA Conference – National Consumers League

burkholder1With only 60 days left for consumers to enroll in the Health Care Marketplace, I joined health care advocates from across the country to hear from healthcare experts at the annual Families USA conference.  Keynote speaker, Vice President Joe Biden, opened the conference with rousing words stating, “Now for the first time, health care coverage for all, is the law of the land.”

The law is a testament to the power of advocates and others, who worked tirelessly to secure this basic right for Americans.

Vice President Biden kicked off the conference with a challenge to remember what life was like before the passage of the Affordable Care Act (ACA) – when pregnancy was a pre-existing condition, young adults were kicked off their parents’ health plan, lifetime dollar limits were in effect, and patients could be denied coverage because of a pre-existing condition.  Americans no longer go to sleep at night worrying that if a family member gets sick, they might lose their house, their savings, and go bankrupt due to high medical bills and inadequate health insurance. “It is not just about physical health coverage anymore, but about peace of mind,” said Biden.

Many speakers, including Biden, noted that the conversation about health care has changed.  Instead of talking about health care as a privilege, it’s now agreed that health care is a right everyone deserves access to.  People who previously had no access to preventive care are going to the doctor and getting much needed care as a result of the ACA.

 

However, the conversation needs to shift to making sure this law works.  The current challenge, as we all know, is getting people enrolled.  As Ezra Klein of The Washington Post noted, “The problem will not be if the website is working properly, the problem will be that some people don’t even have a computer to access a website.” We will need to make sure those populations on the fringe are able to enroll and benefit from the health law.

Kentucky was held up as an example of what can happen when a state opens up its own exchange and recognizes the value of ensuring all its citizens have health insurance. Ranked at the bottom of most national health statistics, Kentucky decided that this was an opportune time to improve its citizens’ health by putting the people before politics. Kentucky is the only southern state to expand Medicaid and open a state-based exchange.  This decision meant providing coverage to nearly 640,000 uninsured people in the state. Expanding Medicaid allows those people who earn too much to qualify for Medicaid and too little to enter into the Marketplace access to coverage under the law. Kentucky Governor Steve Beshear stated that an independent analysis proved that expanding Medicaid will inject over $16 billion into Kentucky’s economy over the next 8 years and create at least 17,000 new jobs. It is clearly a win-win situation.

“The time for politics is over,” proclaimed Klein.  Over 3 million have signed up for private plans through federal and state exchanges as of January 24.  It is expected that a million more will be signing up in January.   As Biden noted, the “ACA is the most consequential piece of legislation” in decades.  Let’s make it work.

Lots to talk about during Talk about Prescriptions Month – National Consumers League

burkholder1By Rebecca Burkholder, NCL Vice President for Health Policy October is Talk about Prescriptions Month, and with 50 percent of Americans taking at least one or more prescription drugs, there are a lot of conversations that need to happen. If you are taking a prescription medication, always ask your doctor or pharmacist why you are taking the medication, its name, how to take it properly, and if there are any side effects. Taking medication as directed is important to obtain the full benefits of the medication; this is especially true if you are taking a medication for a chronic condition.

How you access your medications is also important. This month FDA reminds us that if you buy your medications on line, do so safely. Earlier this month a report released from the National Council on Patient Information and Education (NCPIE) emphasized that with the increased number of Americans with chronic conditions, proper use of mediation is more important than ever.  Today, 27 percent of Americans are living with multiple chronic conditions, and 68 percent (21.4 million people) of Medicare beneficiaries are being treated for at least two concurrent chronic illnesses. Treating multiple chronic conditions accounts for 66 percent of the nation’s health expenditures.  

Of the $300 billion Medicare spent in 2010 on health care, the price tag for treating the 14 percent of beneficiaries with six or more conditions was over $140 billion.  For these patients, poor medication adherence is commonplace and they are at higher risk for medication-related problems and the costly emergency room visits and hospitalizations that can result. The new report, Accelerating Progress in Prescription Medicine Adherence: The Adherence Action Agenda, which was based on input from 23 organizations, including NCL – underscores that as morbidity, mortality and health care costs rise action needs to be taken quickly to improve adherence among Americans living with multiple diseases.  The report outlines a 10-point action agenda that advocates for an increased focus on multiple chronic conditions and policy and programmatic solutions for improving adherence.  

For practical tips on taking medications as directed, especially if you have a chronic condition, see NCL’s Script Your Future website.   In addition to being careful about taking our medications, Americans also need to continue to be mindful about where they purchase medications, especially if buying online. Buying medicines from fraudulent Web sites – which often look legitimate – puts your health at risk because the products may contain the wrong ingredients, too little or too much of the active ingredient, or they might be made with other harmful substances. As a result, consumers may not receive the therapy they need, or they may experience unexpected side effects and possibly get worse. The FDA campaign, BeSafeRx: Know Your Online Pharmacy Web site has a new video featuring FDA’s Health Fraud Coordinator Gary Coody, who explains how to avoid fake online pharmacies. In addition to the “how to” video, the BeSafeRx Web site provides an interactive map for checking a pharmacy’s license through states’ boards of pharmacy, fact sheets, and other materials. For more information about counterfeit drugs, check out our information at Fraud.org.

Clarification on “refill reminder” programs, a win for patients and consumers – National Consumers League

burkholder1By Rebecca Burkholder, NCL Vice President for Health Policy In a significant win for patients and consumers, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued important Guidance on pharmacy-run sponsored medication adherence (i.e., “refill reminder”) programs last week, reinforcing that patient health cannot take a back seat to privacy concerns.

In the wake of widespread confusion following OCR’s January 2013 final rule on medical privacy, the Guidance clarifies that “refill reminder” programs may include a wide array of patient communications, including messages about prescriptions that lapsed within the last 90 days.  OCR clarified that the payments that sponsors (e.g., pharmaceutical companies) provide to pharmacies for running these often costly programs may include all of the pharmacy’s “reasonable direct and indirect costs … including labor, materials, and supplies, as well as capital, and overhead costs.”

As a founding member of the Best Privacy Practices Coalition, the National Consumers League (NCL), strongly supported the final rule’s enhancement of patient privacy and data security protections.  But patient health is an equally important goal. Poor medication adherence is $290 billion problem in this country, resulting in an estimated 125,000 deaths annually.  In an effort to combat this ongoing public health challenge, NCL leads Script Your Future, a medication adherence public awareness campaign with partners across the health care spectrum.  The sponsored “refill reminder” programs addressed in OCR’s Guidance are critical support for our efforts. To help clear up misunderstandings about HHS’s January rule, NCL met with OCR leadership this summer, emphasizing the importance of compliance programs and asking for clarification on the two key issues discussed above. 

We are pleased that OCR heard the concerns NCL and many others expressed and responded with this important Guidance. This much-needed clarification is a big win for patients and, given the September 23, 2013, compliance date of the final rule, arrived in the nick of time.  Recognizing the essential nature of sponsored medication adherence programs, OCR announced that it will not enforce the “refill reminder” provisions of the final rule until November 7, 2013.  This will pave the way for these vital programs to continue, and should encourage those pharmacies -such as CVS -and their sponsors that discontinued their programs in the wake of recent uncertainty to jumpstart them again. The new Guidance is also a win for American consumers. 

The non-partisan Congressional Budget Office estimates that even a very small 1% increase in the number of prescriptions that are refilled translates into more than $1 billion in annual Medicare savings.  By helping address the ever-growing deficit in the Medicare program, OCR’s Guidance helps save tax dollars and benefits all American consumers. NCL applauds OCR for responding to these concerns and balancing the important public interests of patient privacy with patient health.

Improving medication adherence for people with HIV – National Consumers League

burkholder1By Rebecca Burkholder, NCL Vice President for Health Policy For the last several days I have been in Miami at the 8th International Conference on HIV Treatment and Prevention Adherence.  The conference hosts over 400 delegates from more than 30 countries, who work directly providing care to HIV patients or on HIV research.  The conference provides a forum where state of the art science and adherence research for treating HIV are presented, discussed, and translated into evidence-based approaches. While there has been remarkable progress in HIV medicine over the last several years, allowing us to imagine an end to the HIV pandemic, this is tempered by the real world challenges around adherence and prevention.  The keynote speaker, Dr. Badara Samb, Joint United Nations Programme on HIV/AIDS, made a call to action to treat 15 million with HIV by 2015.  Globally, 34 million people are living with HIV. He noted that there are still barriers to care – millions do not have access to treatment, and millions of others who are HIV positive don’t know it yet since they have not been screened. Many people who do know their status, are not getting treatment due to stigma associated with being HIV positive. General sessions and research presentations focused on various aspects of adherence.  Dr. Ira Wilson, Brown University, moderated an interactive panel of HIV health care providers about how to talk to patients about adherence. The discussion included the following tips:  ask patients open-ended questions about adherence, be non-judgmental, don’t make assumptions about a patient’s ability to understand instructions and information, and ask questions about a patient’s life in order to learn about medication-taking behavior. I was invited to give a workshop on NCL’s Script Your Future campaign to raise awareness of the importance of adherence.  While the campaign currently focuses on three chronic condition areas – respiratory, diabetes, and cardiovascular – there was interest in expanding our campaign to include HIV, since many of those with HIV suffer from other chronic conditions as well. The research and clinical work showcased at the conference, along with the clear dedication and commitment of these health care professionals, is key to the ongoing treatment and prevention of HIV.